Regenerative Medicines: Bone and Joint Applications
| Product Code | BCC00324 |
| Publication Date | October 2009 |
| Publisher | BCC Research |
| Product Type | Report |
| Pages | 269 |
| ISBN Number | not applicable |
Regenerative Medicines: Bone and Joint Applications
This Report:
- Provides a comprehensive overview of the global market for regenerative medicines for bone and joint applications
- Offers the background for demographics underlying the market for bone and joint products
- Contains global market forecasts for regenerative medicines for bone and joint applications, with trends and forecasts for growth through 2014
- Describes the leading bone and joint diseases and disorders using regenerative technologies, including incidence and current methods of treatment
- Discusses regulatory issues affecting regenerative medicine products
- Profiles leading and emerging companies.
Introduction
Regenerative medicine is a relatively large and rapidly evolving segment of the healthcare business. The regenerative medicine industry has been in existence for nearly 25 years. Actual product sales, along with research and development (R&D) expenditures, are projected to amount to approximately $2 billion in economic activity in 2009. Bone and joint applications account for a little more than half of those revenues, or $1.2 billion. The rapid evolution of this business is evidenced by the industry consolidation that has occurred since the first edition of this BCC Research report was published in 2003. In addition, intensive R&D efforts at universities and the National Institutes of Health that focus on cutting-edge technology underscore the importance of this industry.
The key objective of regenerative medicine is the utilization of living cells to repair or replace body tissue damaged by injury, disease, or the aging process. The most successful products have drawn upon multidisciplinary fields such as biology, medicine, engineering, and particularly biomedical engineering. The principal focus in this report is on bone and joint applications; however, other regenerative applications such as dental, neurologic, organ regeneration, cardiovascular, urologic, diabetes, and wound care are important. Stem-cell research is an important component of the sector as well. For example, the successful differentiation of embryonic stem cells into specific cell types is widely sought as a means to treat traumatic spinal-cord injury, as well as diseases such as diabetes, Duchenne muscular dystrophy, heart disease, and vision and hearing loss.
Objectives and Goals of Study
This report focuses on the bone- and joint-related applications and markets for the various categories of regenerative medicine products currently available and projected to be introduced during the 5-year forecast period from 2009 to 2014. Market drivers discussed include an increase in diseases and disorders that will benefit from these products, primarily arthritis, osteoporosis, and various types of bone and joint trauma (e.g., hip fractures, knee injuries); increasing use of non-autograft products by physicians; and innovative devices that incorporate bone- and cartilage-growth-stimulating agents in a regenerative appliance. Products discussed include bone and cartilage grafting and regenerative products derived from autologous, allogeneic, and synthetic sources, as well as electrical stimulators for bone growth and regenerative cartilage products.
Profiles are provided of leading and emerging companies in the bone and joint regenerative medicine markets, along with analyses of the current and future positioning of their products and businesses in this active and rapidly changing market.
Intended Audience
The aim of this report is to provide an overview of regenerative medicine products, both available and emerging, for the treatment of diseases and disorders of the bones and joints. The information and analysis presented are important assets in decision making for managers involved in business development, marketing, market research, product development, mergers and acquisitions, licensing, business management, investment banking, and deal creation, as well as to consultants to the pharmaceutical and biotechnology industries. The study provides a comprehensive analysis of the current markets for regenerative medicine products for bones and joints, relevant applications, and the potential of products in development.
Scope of Report
The U.S. has been the main regenerative medicine market both in terms of R&D innovation and product sales; hence, the scope of the study is mainly U.S., although worldwide developments are discussed where relevant. The Overview section provides a background of the demographics underlying the market for bone and joint products, a definition of regenerative medicine and the technologies involved, and a discussion of regenerative products in development for applications other than bones and joints. Various applications sections describe the leading bone and joint diseases and disorders applicable to regenerative technologies, including incidence and current methods of treatment.
The section on Products provides extensive descriptions and analyses (e.g., comparative analysis) of regenerative products used to treat bone and joint disorders, as well as a discussion of products in development.
The section on FDA clinical trials and newly approved products provides a discussion of regulatory issues affecting regenerative medicine products.
An extensive Company Profiles section provides a concise exploration of leading and emerging companies in the area of regenerative products for bones and joints, including product introductions, patents, and overall business strategies.
Methodology
Both primary and secondary research methodologies were used to prepare this market research report. The base year for this study is 2009. Sales data are estimated in nominal dollars (unadjusted for inflation). Information to prepare this study was derived from market intelligence provided by chief executive officers, marketing strategists, research executives, and others at leading companies involved in the regenerative medicine market. Data was accessed from government agencies and regulatory bodies that monitor and/or regulate medical devices. Searches of secondary material such as company annual reports and 10Ks, journal articles, prospectus assessments, government resources, and data from healthcare institutions were conducted.
Information Sources
The information and analyses presented in this report are based on an extensive survey of the biotechnology and pharmaceutical industries, as well as a detailed examination of published literature and reports obtained from regulatory authorities, medical research institutions, pharmaceutical trade associations, and national and world health organizations.
Contents
- Chapter- 1: Introduction -- Complimentary
- Objectives and Goals of Study
- Intended Audience
- Scope of Report
- Methodology
- Information Sources
- Analyst Credentials
- Related BCC Reports
- BCC Online Services
- Disclaimer
- Chapter-2: Summary
- Summary Table U.S. Market for Regenerative Medicine Products Used in Bone and Joint Applications, through 2014 ($ Millions)
- Summary Figure U.S. Market for Regenerative Medicine Products Used in Bone and Joint Applications, 2007-2014 ($ Millions) 6
- Chapter-3: Overview and Overall Status of The Industry
- Total Scope of Regenerative Medicine Market
- Table 1 Functional Activities with Regenerative Medicine Sector
- How Regenerative Medicine Works
- Tissues and Organs on Demand
- Organ Replacement Is A $100 Billion per Year Business
- Examples of Impact on Existing Conditions and Diseases
- Barriers to Regenerative Medicine
- Current R&d Priorities
- Table 2 Principal Regenerative Medicine Business R&d Focuses
- Table 3 20-Year Planning Horizon for Regenerative Medicine Business: Likely Developments, 2015-2030
- Total Output of The Sector
- Regenerative Medicine and Healthcare Economics
- Population Trends
- Market Timing
- Overseas Initiatives
- Chapter-4: Principle Approaches to Regenerative Medicine
- Gene- and Protein-Based Approaches
- Antibodies
- The Importance of Antibody Drugs
- Advantages of Monoclonal Antibody Drugs
- Antibodies and Osteoarthritis
- Growth Factors
- How Bmps Function
- Table 6 Bone Morphogenetic Proteins
- Clinical Uses
- Companies
- Cells and Tissues
- Tissue Engineering
- Artificial Skin
- Cartilage
- Other Approaches to Cartilage
- Biosynthetic Composites for Cartilage Repair
- The Market for Tissue-Engineered Cartilage Products
- Table 7 U.S. Market for Tissue-Engineered Cartilage Products, through 2014 ($ Millions)
- Other Products
- Creation of Entire Organs
- Embryonic Stem Cells
- Novel Materials and Biomaterials 48
- Chapter-5: Products and Technologies: Categories of Regenerative Medicine
- Chapter-6: Stem Cell Therapies and Regenerative Medicine
- Stem Cells as Potential Replacement Cells
- Technical Impediments
- Overview of Funding
- Table 8 Federal Funding for Stem Cell Research, through 2008 ($ Millions)
- State-Level Initiatives for Stem Cell Research
- Table 9 State Level Programs Focused on Stem Cell Research
- Potential Applications: Current Status
- in Vivo Reprogramming
- Umbilical Cord Blood Stem Cells
- Recent Research Developments
- Induced Pluripotent Stem Cells
- Recent Research Developments
- Adult Multipotent Stem Cells
- Embryonic Stem Cells
- Geron and The First Human Trials
- Other Stem Cell Research
- Status of Other Clinical Trials
- Stem Cell Therapy for Als
- Stem Cell Therapy for Duchenne Muscular Dystrophy
- Stem Cell Therapy and Bone Marrow Transplants
- Stem Cell Therapy and ... (Continued) 66
- Chapter-7: Regenerative Products to Treat Bone Diseases
- Materials for Bone Tissue Repair
- Inherent Regeneration of Bone
- Overall Size of Bone Graft Business
- Bone Graft Substitutes
- Allograft Tissue
- Other Osteoconductive Bone Graft Substitutes
- Hydrogels and Regeneration
- Composition and Method for Self-Assembly and Mineralization of Peptide Amphiphiles
- Chondroitinase Abc I Polynucleotides
- Abstract
- Transdiscal Administration of Cycline Compounds
- Abstract
- Composition and Method for Preparing Biocompatible Surfaces
- Abstract
- Spinal Mobility Preservation Apparatus Having An Expandable Membrane
- Abstract
- Major Diseases and Conditions Affecting Bones
- Osteoporosis
- Currently Available Products to Treat Osteoporosis
- Bisphosphonates
- Fosamax
- Boniva
- Table 19 Drugs Used to Treat Osteoporosis
- Hormones
- Evista
- Forteo
- Forteo (Continued)
- Forteo (Continued)
- Miacalcin
- Steroids and Osteoporosis
- Glucocorticoids
- The Market for Products to Treat Osteoporosis
- Table 20 Worldwide Market for Drugs to Treat Osteoporosis, through 2014 ($ Millions)
- Figure 4 Worldwide Market for Drugs to Treat Osteoporosis, 2007-2014 ($ Millions)
- Paget' S Disease
- Drugs Currently Available to Treat Paget' S Disease
- Actonel
- Aredia
- Skelid
- Zometa
- The Market for Products to Treat Paget' S Disease
- Table 21 Worldwide Market for Drugs to Treat Paget' S Disease, through 2014 ($ Millions)
- Figure 5 Worldwide Market for Drugs to Treat Paget' S Disease, 2007-2014 ($ Millions)
- Injuries and Degenerative Conditions
- Hip Fractures
- Table 22 Worldwide Hip Fracture Volumes, through 2014
- Table 23 U.S. Hip Fracture Volumes, through 2014
- Traditional Treatments for Bone and Joint Disorders
- Table 24 U.S. Market Shares for Musculoskeletal Products, 2008 (%)
- Table 25 U.S. Reconstructive Device Market, 2008 (%)
- Market Leaders
- Joint-Replacement Surgery
- Table 26 Hip Replacement Procedure Volumes, U.S., through 2014
- Table 27 Historical Rates of Hip Replacemen in Six Major States, 2001
- Table 28 Worldwide Hip Replacement Market, through 2014 ($ Millions)
- Figure 6 Worldwide Hip Replacement Market, 2007-2014 ($ Millions)
- Table 29 U.S. Hip Replacement Market, through 2014 ($ Millions)
- Figure 7 U.S. Hip Replacement Market, 2007-2014 ($ Millions)
- Knee Replacements
- Table 30 Worldwide Knee-Replacement Procedure Volumes, through 2014
- Table 31 U.S. Knee Replacement Procedure Volumes, through 2014
- Table 32 Worldwide Knee Replacement Market, through 2014 ($ Millions)
- Figure 8 Worldwide Knee Replacement Market, 2007-2014 ($ Millions)
- Table 33 U.S. Knee Replacement Market, through 2014 ($ Millions)
- Figure 9 U.S. Knee Replacement Market, 2007-2014 ($ Millions)
- Table 34 U.S. Market for Unicondylar Knee Replacement, through 2014 ($ Millions)
- Figure 10 U.S. Market for Unicondylar Knee Replacement, 2007-2014 ($ Millions)
- Natural Therapeutic Treatments for Arthritis
- Imaging and Regeneration
- Chapter-8: Regenerative Applications for Bones and Joints
- Chapter-9: Electrical Bone Growth Stimulator Market
- Overview
- Scientific Basis
- Ultrasonic Osteogenesis Stimulators for Bone Healing
- Marketers of Invasive and Noninvasive Electrical Bone Growth Stimulators
- Biomet
- Orthofix
- Djo, Inc
- Smith & Nephew
- Market Size
- Table 35 Worldwide Market for Noninvasive Bone Growth Stimulators, through 2014 ($ Millions)
- Table 36 U.S. Market for Noninvasive Bone Growth Stimulators, through 2007 ($ Millions) 142
- Chapter-10: Orthopedics - Fda Clearances and New Product Development
- Suppliers of Regenerative Bone and Joint Products
- Table 37 Recently Approved Orthopedic Bone and Joint Devices by Product, Company, and Approval Date, 2008 - 2009
- Chapter-11: Market for Tissue Engineering Products
- Tissue Engineering and Cell Therapy
- Research Initiatives
- Research Initiatives (Continued)
- Research Initiatives (Continued) 162
- Chapter-12: Regenerative Concepts and Products in Dentistry
- Overview
- Indications and History
- Charactertistics and Materials
- Barrier Membranes
- Non-Resorbable
- Resorbable
- Collagen Resorbable Membranes
- Synthetic Resorbable Membranes 165
- Chapter-13: Skin Technologies
- Skin Technologies (Continued)
- Skin-like Tissue Developed from Human Embryonic Stem Cells
- Table 38 Sales of Engineered Skin Grafts and Replacements, through 2014 ($ Millions) 168
- Chapter-14: Neurological Applications in Regenerative Medicine
- Overview
- Neurodegenerative Diseases
- Current Conventional Therapies for The Treatment of Neurodegenerative Disease Symptoms
- Spinal Cord Injury, Neurodegenerative Diseases, and Regenerative Potential
- Spinal Cord Injury, ... (Continued)
- University of Southern California (Usc) 172
- Chapter-15: Regenerative Medicine and Applications in Cardiac Care
- Overview
- Stem Cells for The Future Treatment of Heart Disease
- Particular R&d Priorities
- Particular R&d Priorities (Continued)
- Stem Cells and Biological Pacemakers
- Heart Progenitor Cells Developed from Embryonic Stem Cells
- Other Current Regenerative Medicine as IT Relates to The Heart
- Chapter-16: Regenerative Medicine and Diabetes
- Background
- Possible Applications for Regenerative Medicine
- Possible Applications for ... (Continued) 180
- Chapter-17: Fda Approved Clinical Trials Involving Regenerative Medicine
- Current Status of The Regenerative Medicine Business
- Regulatory Environment
- Regulatory Environment (Continued)
- Status of Research and Clinical Trials
- Analysis of Clinical Trials
- Table 39 Regenerative Medicine Clinical Trials by Major Category
- Table 40 Current Clinical Trials in The Field of Regenerative Medicine Status, Conditions, Intervention, and Sponsor 185
- Chapter-18: Overseas Activities
- Domestic Versus Overseas Regenerative Medicine Companies
- Japan
- Europe
- Australia and China 212
- Chapter-19: Patent Analysis
- Analysis
- Tissue Engineering Patents
- Table 41 Most Frequently Cited Patent Assignees in Tissue Engineering Field
- Geographic Distribution
- Table 42 World Distribution of Regenerative Medicine Patents Issued, 1985 - 2009 (%)
- Recent Patents
- Direct Differentiation Method for Making Cardiomyocytes from Human Embryonic Stem Cells
- Abstract
- Method for Preparing Novel Transcription Factors and Use
- Abstract
- Endoderm Cells from Human Embryonic Stem Cells
- Abstract
- Genes with Es Cell-Specific Expression
- Abstract
- Marker System for Preparing and Characterizing High-Quality Human Embryonic Stem Cells
- Abstract 217
- Chapter-20: Company Profiles
- Table 43 Publically Traded Companies in The Regenerative Medicine Industry, as of July 1, 2009
- Aastrom Biosciences, Inc
- Advanced Biohealing, Inc
- Advanced Cell Technology, Inc
- Aesculap, Inc
- Aldagen, Inc
- Alphatec Spine, Inc
- Angiotech Pharmaceuticals, Inc
- Arteriocyte Medical Systems, Inc
- Arthrex, Inc
- Arthrocare Corporation
- Biomet, Inc
- Biomimetic Therapeutics, Inc
- Biotissue Technologies Gmbh
- Capstone Therapeutics
- Centerpulse Orthopaedics, Inc
- Cerapedics, Inc
- Citagenix, Inc
- Conmed Corporation
- Crosscart Inc
- Cryolife, Inc
- Curis
- Cytori Therapeutics, Inc
- Depuy Orthopaedics, Inc. (Unit of The Depuy Companies)
- Djo Surgical
- Esbatech Ag
- Etex Corporation
- Exactech, Inc
- Fate Therapeutics, Inc
- Garnet Biotherapeutics
- Genzyme Biosurgery
- Geron Corporation
- Integra Lifesciences Holding Corp
- Isotis Orthobiologics, Inc. (Integra Orthobiologics)
- International Stem Cell
- Interpore Cross International
- Isto Technologies, Inc
- Kensey Nash Corporation
- Lifecell (A Subsidiary of Kinetic Concepts, Inc.)
- Mcewen Centre for Regenerative Medicine
- Mcgowan Institute for Regenerative Medicine
- Medtronic, Inc
- Mesoblast, Limited
- National Center for Regenerative Medicine
- National Tissue Engineering Center (Ntec)
- Neuralstem
- Novabone Products, Llc
- Novartis Corporation
- Novocell, Inc
- Opexa Therapeutics
- Organogenesis Inc
- Orthofix International N.V
- Orthopeutics, L.P
- Orthovita, Inc
- Osiris Therapeutics, Inc
- Osteotech, Inc
- Pfizer, Inc
- Pluristem Therapeutics
- Regen Biologics, Inc
- Reneuron
- Rti Biologics, Inc
- Scil Technology Gmbh
- Smith and Nephew
- Stemcells, Inc
- Stemcor Systems, Inc
- Straumann USA Llc
- Stryker Corp
- Synthes, Inc
- Tengion
- Tepha
- Thermogenesis Corp
- Tigenix N.V
- Ucb S.A. (Headquarters)
- Wake Forest Institute for Regenerative Medicine
- Wright Medical Group, Inc
- Zimmer Holdings, Inc
- Other Organizations Involved in Regenrerative Medicine R&d
- Academic Institutions
- U.S. Government
- Other Societies and Organizations 262
- Chapter-21: Glossary of Key Terms in Regenerative Medicine Business
- Glossary of Key Terms